品質(zhì)管理系統(tǒng)QMS課件

葵花寶典:品質(zhì)管理系統(tǒng)/QMS(e.g.ISO9001/9004:2000,QS-9000,ISO/IEC17025,ISO/TS16949…等)

之推行&稽核(ConceptualApplication&AssessorHandbook)PresentedbyRockChangCountryManagerUnderwritersLaboratoriesInc.(Taiwan)Issued:May28,2001Revised:October15,2002(簡(jiǎn))1葵花寶典:品質(zhì)管理系統(tǒng)/QMSCourseObjectives–

也算是「知識(shí)管理」(KnowledgeManagement)當(dāng)中的一種「知識(shí)呈現(xiàn)」/「知識(shí)成文化」(KnowledgeRepresentation):將「內(nèi)隱知識(shí)」(ImplicitKnowledge)成文化、外化，成為「外顯知識(shí)」(ExplicitKnowledge),再和大家分享(KnowledgeSharing)!

企業(yè)知識(shí)乃指能有效解決問(wèn)題的方法及資訊，又可分為「外顯知識(shí)」及「內(nèi)隱知識(shí)」。2CourseObjectives–2說(shuō)明:「外顯知識(shí)」是指可以有系統(tǒng)的語(yǔ)言來(lái)表示的知識(shí)(e.g.企業(yè)的內(nèi)部ISO文件&記錄…等)，「內(nèi)隱知識(shí)」則指無(wú)法以正式的方法表達(dá)及溝通的知識(shí)。(e.g.隱藏在個(gè)別員工腦袋裡的專門技術(shù)或經(jīng)驗(yàn))。由於外顯知識(shí)才能被傳播、擷取和再使用，因此如何將「內(nèi)隱知識(shí)」轉(zhuǎn)化成「外顯知識(shí)」是企業(yè)或個(gè)人知識(shí)管理的重要課題之一，尤其是對(duì)一些知識(shí)型產(chǎn)業(yè)，知識(shí)型工作者，高附加價(jià)值製造業(yè)…。3說(shuō)明:「外顯知識(shí)」是指可以有系統(tǒng)的語(yǔ)言來(lái)表示的知識(shí)(e.g「知識(shí)管理」之終極目的是「知識(shí)創(chuàng)新創(chuàng)值」:實(shí)施知識(shí)管理所倚重的不是資訊科技，而是一套鼓勵(lì)員工不斷創(chuàng)新創(chuàng)值的制度與文化，如讓基層員工參與研發(fā)，允許工作人員犯錯(cuò)(但不可第二次犯相同的錯(cuò))，其對(duì)員工的尊重，使得該公司能得以從知識(shí)管理進(jìn)入知識(shí)創(chuàng)造的境界，自然能不斷的創(chuàng)新。組織不陷入僵化的做法，就是在創(chuàng)新的精神下創(chuàng)造一個(gè)環(huán)境，讓企業(yè)內(nèi)能發(fā)生創(chuàng)造性的摩擦和建設(shè)性的對(duì)立，如此則可有良性循環(huán)產(chǎn)生，企業(yè)有源源不絕的創(chuàng)新觀念和行動(dòng)，使企業(yè)永遠(yuǎn)具有競(jìng)爭(zhēng)力。而創(chuàng)新是必須注意到人文面，才是成功。4「知識(shí)管理」之終極目的是「知識(shí)創(chuàng)新創(chuàng)值」:4ISO/TS16949:2002之:Employeemotivationand

empowerment(員工激勵(lì)與授/賦權(quán))Theorganizationshallhaveaprocesstomotivateemployeestoachievequalityobjectives,tomakecontinualimprovements,andtocreateanenvironmenttopromoteinnovation.Theprocessshallincludethepromotionofqualityandtechnologicalawarenessthroughoutthewholeorganization.(組織必須有一流程來(lái)激勵(lì)員工,以達(dá)成品質(zhì)目標(biāo),進(jìn)行持續(xù)改善,以及建立一個(gè)能鼓勵(lì)創(chuàng)新之環(huán)境。此流程需包括將品質(zhì)及科技意識(shí)推廣至整個(gè)組織內(nèi)。)5ISO/TS16949:2002之:5Data(8.4)InformationKnowledge(ispower):ISO9004:2000Managementshouldtreat「data」(8.4Analysisofdata)asafundamentalresourceforconversionto「information」andthecontinualdevelopmentofanorganization’s「knowledge」,whichisessentialfor「makingfactualdecisions」(7thQualityManagementPrinciple--Factualapproachtodecisionmaking/Managementby(quality)Objective/CI/CA/PA)andcanstimulate「innovation」(「知識(shí)創(chuàng)新」e.g.7.3–Design&Development)。6Data(8.4)InformationKnow「創(chuàng)新」:並非指「技術(shù)研發(fā)」和「知識(shí)」本身，而是指取得和應(yīng)用「知識(shí)」和「技術(shù)」能將其轉(zhuǎn)變?yōu)槭袌?chǎng)價(jià)值的能力(i.e.「市場(chǎng)價(jià)值」之創(chuàng)造)。這種「市場(chǎng)價(jià)值」乃經(jīng)由「市場(chǎng)競(jìng)爭(zhēng)」比較而來(lái),而其最後之抉擇則在於滿足顧客需要的能力(i.e.目前政府大力推動(dòng)之Innovalue「創(chuàng)新價(jià)值」)。郭臺(tái)銘說(shuō)，對(duì)於一家公司而言，創(chuàng)新指的是速度、彈性、價(jià)格與品質(zhì)的更佳化。7「創(chuàng)新」:並非指「技術(shù)研發(fā)」和「知識(shí)」本身，而是指取得和企業(yè)要靠什麼來(lái)創(chuàng)造價(jià)值?行銷(即了解與掌握顧客的需求Input)與創(chuàng)新(即為顧客提出有效的解決方法Output):Processapproach!個(gè)人覺(jué)得LearningOrganization(或OrganizationalLearning)的真正精神是

Double-loopLearning:Tactical(Operational),StrategicFeedback&Learning!e.g.CAR,ECN,SWOT,FMEA,BSC…8企業(yè)要靠什麼來(lái)創(chuàng)造價(jià)值?8為何有新版ISO9001:2000?目的?

應(yīng)付(更適合)小公司(SmallBusinesses)「小而美」(ISO9001:1994不太適用小公司)

更適合「各行各業(yè)」(ISO9001:1994年版傾向於製造業(yè)之用)

更簡(jiǎn)單易懂

1994年版20個(gè)條文之問(wèn)題:「ISO9001:1994→auditor-friendly(easytoauditbutdifficultfororg.)」vs.「ISO9001:2000→organization-friendly」

和ISO14001相容

「品質(zhì)管理系統(tǒng)」(QMS)和「作業(yè)流程」(BusinessProcesses)

相結(jié)合:「新版ISO9001focuseson“howtomanageabusinesstoachieveplanned/desiredresults(i.e.effectiveness),notonindividualclauses”」vs.「舊版20個(gè)條文:“Thesuppliershall….”」

9為何有新版ISO9001:2000?目的?9更強(qiáng)調(diào)「持續(xù)改善」和「客戶滿意」幾乎是向QS-9000靠攏強(qiáng)調(diào)高階管理階層之參與(EmphasisonTopManagement):條文5強(qiáng)調(diào)「一張?jiān)^書涵蓋總公司/旗下多廠」之認(rèn)証模式(EmphasisonCorporateRegistration/Certification):更c(diǎn)ost&QMSeffective!UL不會(huì)為了多一些income而故意隱瞞此點(diǎn)!Beyondcertificationtowardsperformanceimprovement.10更強(qiáng)調(diào)「持續(xù)改善」和「客戶滿意」10Newstructureofthestandardsshouldnotobligeorganizationstochangetheirsystemdocumentationtomatchthestructureofthestandards.Systemdocumentationisuniquetoeachorganization.RequirementsfromtheoldISO9001:1994havebeeneither:Maintained(Example-purchasing)Simplified(Example-calibration)Eliminated(Example-documentation)Structurechanges11NewstructureofthestandardsFeaturesofISO9001:2000Mostrequirementscomefromeither:8QualityManagementPrinciples1994versionofISO9001ISO14001:1996QS-9000(Automotiveindustry)12FeaturesofISO9001:2000MostSinglerequirementsstandard(nomoreISO9002/3)NeedforclearscopestatementsClause1.2“Application”(ISO/TC176GuidanceDocument+IAFCommunique)Specialsignificanceof“Design&Development”ProcessapproachandPDCAComparison(MaybealittleunfaironISO9001:1994!)ISO9001:1994“Documentedproceduresevidencedbyrecords”ISO9001:2000“Definedandmanagedprocessesevidencedbyresults”1313新版ISO9001:2000稽核方式(Assessment

Philosophy)有那些變更?

文件化要求大幅減少只剩「九項(xiàng)強(qiáng)制要求」和「公司自覺(jué)有必要之文件」: 書面化之「品質(zhì)政策」,「品質(zhì)目標(biāo)」 「品質(zhì)手冊(cè)」,「文件管制」,「記錄管制」,「內(nèi)部稽核」,「不良品管制」,「矯正措施」和「預(yù)防措施」。14新版ISO9001:2000稽核方式(Assessm註:Procedure(ISO9000:20003.4.5)SpecifiedwaytocarryoutanactivityoraprocessNOTE1procedurescanbedocumentedornot.NOTE2Whenaprocedureisdocumented,theterm“writtenprocedure”or“documentedprocedure”isfrequentlyused.Thedocumentthatcontainsaprocedurecanbecalleda“proceduredocument”.判定「是否符合規(guī)定」:彈性更大!QMSdrivenbyqualitypolicy,qualityobjectivesandcontinuousimprovementtargets(由「品質(zhì)政策」,「品質(zhì)目標(biāo)」及「持續(xù)改善目標(biāo)」來(lái)驅(qū)動(dòng)「品質(zhì)管理系統(tǒng)」!)15註:15※TL90004.1.1QualityObjectives--ObjectivesforqualityshallincludetargetsfortheTL9000metricsdefinedintheTL9000QualitySystemMetricshandbook.註:QMS代表「QualityManagementSystem」(品質(zhì)管理系統(tǒng))。16※TL90004.1.1QualityObjecti

QMS和「作業(yè)流程」(BusinessProcesses)相結(jié)合.

:

:所以,AR(缺點(diǎn)ActionRequest)如“Thepracticeof….isnotdocumentedinprocedure”是不能再開的!FlexibleRequirements:「是否符合規(guī)定」之彈性更大! *Assessors更被挑戰(zhàn)要去接受各式各樣能符合規(guī) 定(intent)之「方法/方式」(approaches/ways) *DOESNOTmeanassessorswillacceptless objectiveevidenceofcompliance(上述之意涵不表示assessors將接受更少之客觀證據(jù)就能符合要求!)17QMS和「作業(yè)流程」(BusinessProcesAssessors將需更注重以「是否達(dá)成組織所訂定之量化之(策略性)目標(biāo)」來(lái)量測(cè)「品質(zhì)管理系統(tǒng)」(QMS)之執(zhí)行效果(effectiveness). -ISO9001:2000之4個(gè)主要流程(processes)和一般之「作業(yè)流程」(BusinessProcesses)相類似. *Assessors將花更多時(shí)間來(lái)稽核「作業(yè)系統(tǒng)」(BusinessSystems)和「作業(yè)流程」(BusinessProcesses),因大部分公司均將「品質(zhì)目標(biāo)」(QualityObjectives)和「營(yíng)業(yè)目標(biāo)」(BusinessObjectives)整合在一起.e.g.QMS和上市(櫃)「9大循環(huán)」(內(nèi)控系統(tǒng))結(jié)合；QMS和ERP/SCM/CRM結(jié)合(物流，金流，資訊流—零庫(kù)存/JIT，「e化/M化/IT技術(shù)」之應(yīng)用…)。組織進(jìn)行「e化/M化」必會(huì)導(dǎo)致「作業(yè)流程」，「工作模式」之改變！18Assessors將需更注重以「是否達(dá)成組織所訂定之量化之*ISO9001:2000各個(gè)「子條文」之process(sub-clauseprocess)之執(zhí)行效果將被用來(lái)決定4個(gè)主要processes(條文5~8)之執(zhí)行效果。八大品質(zhì)管理原則(eightqualitymgmtprinciples)Topmgmt應(yīng)使用下列八大原則來(lái)達(dá)到「績(jī)效提昇」(improvedperformance):Customerfocus(客戶導(dǎo)向/以客為尊/替客戶加值): 要先決定「客戶」是誰(shuí)？e.g.學(xué)校:maybe學(xué)生、家長(zhǎng)(出錢的)，將來(lái)的僱主(processout之使用者)，繳稅之community社區(qū)大眾(公立學(xué)校)…。

Clause5.2-Topmanagementshallensurethatcustomerrequirementsaredeterminedandaremetwiththeaimofenhancingcustomersatisfaction. 19*ISO9001:2000各個(gè)「子條文」之procesRemarks:並不表示TopMgm’t需要親自參與「合約/訂單審查」。重點(diǎn)是TopMgm’t要「確定」(ensure→可以delegation「授權(quán)」)有一個(gè)process存在用以確定組織內(nèi)之人員都知道「客戶需求」之重要性，並且要符合「客戶需求」7.2Customer-relatedprocess7.2.3Customercommunication8.2.1Customersatisfactione.g.豐田汽車及國(guó)外一些兒童玩具公司之「讓消費(fèi)者全程參與商品開發(fā)—讓消費(fèi)者成為研發(fā)團(tuán)隊(duì)之“Customer-in”概念」之落實(shí)。 20Remarks:並不表示TopMgm’t需要親自參與「合Leadership(領(lǐng)導(dǎo)統(tǒng)御/領(lǐng)導(dǎo)風(fēng)格):e.g.麥克?波特大師主張「策略競(jìng)爭(zhēng)」，強(qiáng)調(diào)「貫徹策略的唯一辦法就是要有非常強(qiáng)的領(lǐng)導(dǎo)！」 clause5的TopMgmtInvolvement. 5.1Mgmtcommitment:Orgcan’thireaconsultanttowriteaprocedurefor(top)mgmtcommitment!3.Involvementofpeople(全員參與)TL90004.1.1.C.1Mgmtwithexecutiveresponsibilityshoulddemonstratetheiractiveinvolvementinlong-andshort-termqualityplanning.QS-9000APQP各階段之收尾所要求的“MgmtSupport”.QMS之推動(dòng)絕非只是QA之責(zé)任21Leadership(領(lǐng)導(dǎo)統(tǒng)御/領(lǐng)導(dǎo)風(fēng)格):e.g.麥克4.Processapproach流程(過(guò)程)導(dǎo)向或方式:品質(zhì)看得見，「過(guò)程」是關(guān)鍵！e.g.組織進(jìn)行「e化/M化」(Mobilize化:行動(dòng)商務(wù)MCommerce)→改變「作業(yè)流程」→也是一種C.I.ISO9001:2000版與舊版ISO最大不同處在於「新版是以流程為導(dǎo)向的品質(zhì)管理系統(tǒng)，使管理者易於採(cǎi)取監(jiān)控、量測(cè)、分析與改善等管理手法(i.e.更著重於作業(yè)流程之管理、改善與創(chuàng)新)，比起舊版ISO(以條文為導(dǎo)向)更能有效監(jiān)督企業(yè)內(nèi)部各流程之運(yùn)作及有效性」。224.Processapproach流程(過(guò)程)導(dǎo)向或方5.Systemapproachtomgmt(管理interrelatedprocesses之系統(tǒng)管理): e.g.4大processes(mgmt,resource,production/service-provision,MAI…等)之有效管理&linkagescreate“synergy(綜效)”&integration(整合)–thewholeexceedsthesumoftheparts.

打破functional&departmentalbarriers/silos/boundaries(viacommunication..):「打破藩籬(內(nèi)牆及外牆)」!GE’s“Boundaryless(無(wú)界限)概念”!6.Continualimprovement(持續(xù)改善):“Good-Better-Best”“Better(Q)-Cheaper(C)-Faster(D)”7.Factualapproachtodecisionmaking(以事實(shí)/資料為根據(jù)之決策):Clause8e.g.Asaying:「Ifyoucan’tmeasureit,youcan’tmanageit!」(如果你不能衡量它，就無(wú)法管理它!)e.g.Pilesandpilesofrecordsgatheredbutsittheretocollectdust….。235.Systemapproachtomgmt(管理8.Mutuallybeneficialsupplierrelationships(互利之中衛(wèi)體系關(guān)係):打破「外牆」!NotstronglyincorporatedinISO9001:2000,butinISO9004:2000.但可以延伸看成inter-departments/internalcustomers之關(guān)係:breakingthebarriersbetweendepartments.(打破「內(nèi)牆」!)

e.g.英航將外包作業(yè)發(fā)揮的淋漓盡致；「企業(yè)合併」是為了達(dá)到預(yù)期之「綜效」(Synergy):1+12?Whatif內(nèi)鬥/內(nèi)耗，勾心鬥角而形成「空轉(zhuǎn)」…?(astory:…interviewee反問(wèn)interviewer:「你要多少?」結(jié)果他被錄取了!)以上八大原則構(gòu)成ISO9000系列標(biāo)準(zhǔn)之基礎(chǔ)。248.Mutuallybeneficialsupplie注意:前3項(xiàng)(Customerfocus,Leadership&Involvementofpeople)是屬於softrequirements(hardertoaudit!)*21世紀(jì)強(qiáng)調(diào)「顧客第一，員工第二，服務(wù)第三，老闆最後」的領(lǐng)導(dǎo)觀念。TS16949:2002NOTETheknowledgeanduseoftheeightqualitymanagementprinciplesreferredtoinISO9000:2000andISO9004:2000shouldbedemonstratedandcascadedthroughtheorganizationbytopmanagement.備註

八項(xiàng)品質(zhì)管理原則（參考ISO9000:2000和ISO9004:2000）的知識(shí)和應(yīng)用，應(yīng)由高階管理階層加以示範(fàn)並由上而下展開至整個(gè)組織。

25注意:前3項(xiàng)(Customerfocus,LeaderFAQ:「ISO9001:1994轉(zhuǎn)換至ISO9001:2000」會(huì)增加很多成本嗎？答:a)對(duì)於一些原先QMS之推行就很扎實(shí)，健全之公司(e.g.一些體質(zhì)良好之High-techIndustry)而言，不是大問(wèn)題。因?yàn)檫@些公司一開始就都很專注於「流程導(dǎo)向/方式」&「持續(xù)改善」，「高階管理階層參與」，有很好之process來(lái)瞭解「客戶需求」及有效監(jiān)控及量測(cè)是否符合「客戶需求」，甚至將其結(jié)合至有效之「品質(zhì)目標(biāo)」及「客戶滿意度」管理….。26FAQ:「ISO9001:1994轉(zhuǎn)換至ISO9001b)但是對(duì)於一些平常就欠缺「流程導(dǎo)向」(ProcessFocus)之公司，可能就有問(wèn)題。這些公司可能僅有將ISO9001:1994之20個(gè)條文做成文件，並不真正了解這20個(gè)條文如何和「作業(yè)流程」(BusinessProcesses)之間之連結(jié)及交互作用；換言之，他們沒(méi)有真正了解及落實(shí)clause4.1:組織必需先「管理其流程」…(theorganizationmuststartmanagingitsprocesses…)。同時(shí)，他們距離達(dá)到上述a)之水準(zhǔn)還有一大段距離….。Remarks:許多通過(guò)ISO9001:1994之公司之QMS常被詬病為「由20個(gè)不怎麼相關(guān)之活動(dòng)之鬆散結(jié)合，而不是緊密環(huán)環(huán)相扣之系統(tǒng)性結(jié)合/管理」(manyISO9001:1994compliantsystemswereactuallyaloosecollectionof20semirelatedactivitiesratherthanasystematicapproachtomanagement.)。27b)但是對(duì)於一些平常就欠缺「流程導(dǎo)向」(ProcessF新版ISO9001:2000只剩ISO9001，不像1994年版的有分ISO9001,ISO9002&ISO9003，因此需特別注意7.3DesignandDevelopment(設(shè)計(jì)與開發(fā))有無(wú)被排外(exclusion)之問(wèn)題。Exclusion(排外)ofISO9001:2000requirements“NotApplicable”duetothenatureofanorganizationanditsproduct:由於組織及其產(chǎn)品之「性質(zhì)」(nature)不同之關(guān)係，可能新的ISO9001:2000標(biāo)準(zhǔn)有某些條文可以不適用，那麼這些不適用之情況可以被考慮當(dāng)成「排外」(exclusion)。Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtoreqmtswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryreqmts.28新版ISO9001:2000只剩ISO9001，不像19該「排外」(exclusions)只限制適用於「條文7」(clause7):“產(chǎn)品實(shí)現(xiàn)ProductRealization”之條文，且該「排外」不能影響到組織為供應(yīng)能符合客戶和法規(guī)要求之產(chǎn)品之該組織之「能力」(ability)或「責(zé)任」(responsibility).和QS-9000觀念一致.常見之「排外」(Exclusions): 7.3DesignandDevelopment「設(shè)計(jì)與開發(fā)」:(MajorARifQMaddressesN/Afor….)29該「排外」(exclusions)只限制適用於「條文7」 7.5.2ValidationofProcesses(SpecialProcesses) 「特殊製(流)程」

7.5.3IdentificationandTraceability「識(shí)別與追溯」這個(gè)clause可能是partiallyapplicable，亦即“Identification”部分是applicable(不能排外)，但如果對(duì)組織之產(chǎn)品而言，並沒(méi)有特定之追溯要求時(shí)，則Traceability可排外。 7.5.4CustomerProperty「客戶財(cái)產(chǎn)」

假如客戶提供「原始設(shè)計(jì)」給工廠製造，此即構(gòu)成所謂的「智慧財(cái)產(chǎn)」(IP:IntellectualProperty)而算是「客戶財(cái)產(chǎn)」，必需納入組織之QMS之中。(MinorARifQMaddressesN/Afor…)

7.6UseofMeasuringandMonitoringDevices「量測(cè)與監(jiān)控儀器之使用」(例如一些服務(wù)業(yè)不需用到量具時(shí),buthowabout加油站，葬x社，x儀館…?)30 7.5.2ValidationofProcessesWheretheoverallresponsibilityforproductrealizationbelongstoanorganization,processoutsourcing(某些“流程”外包)isnotvalidjustificationforexclusion:「當(dāng)組織對(duì)產(chǎn)品實(shí)現(xiàn)負(fù)全責(zé)時(shí)，將某些過(guò)程/流程(processes)外包出去」並非有效之「排外」(exclusions)之理由。(參閱後續(xù)之AppriopriateControl之itemH和StrongerPurchasingControl兩部分之詳細(xì)說(shuō)明)Remarks:假如公司將design委外給沒(méi)有通過(guò)ISO9000之公司時(shí),Scope為「TheManagementofsubcontracted(或outsourced)XXX(產(chǎn)品名稱)design.ThemanufactureofXXX(產(chǎn)品名稱)」。假使是委外給通過(guò)AccreditedISO9000之公司時(shí),Scope之寫法可以寫成「ThedesignandmanufactureofXXX(產(chǎn)品名稱)」。Regulatory/CustomerPermissiontoexcludeapplicablerequirementsnotvalidjustification.:「法規(guī)或客戶允許可以將某些該適用之條文排外」並非有效之「排外」理由。31Wheretheoverallresponsibilie.g.A廠為取得ISO9002:1994之一生產(chǎn)某種riskclass之醫(yī)療器材廠，法規(guī)並沒(méi)有強(qiáng)制要求生產(chǎn)此種醫(yī)療器材之製造商一定要將設(shè)計(jì)管制納入其QMS之中。在挑戰(zhàn)ISO9001:2000Upgrade時(shí)，因A廠本身確實(shí)有從事此種產(chǎn)品之設(shè)計(jì)與開發(fā)活動(dòng)，而且此種活動(dòng)確實(shí)也會(huì)影響其符合客戶要求之能力(theactivitydoesaffectitsabilitytomeetcustomerrequirements)，因此A廠決定不將7.3(DesignandDevelopment)排除在QMS之外。認(rèn)證範(fàn)圍(ScopeofRegistration)可以只包含部分產(chǎn)品(limitedscope)32e.g.A廠為取得ISO9002:1994之一生產(chǎn)某種rDesignandDevelopment

看IAFGuidance2.假如組織對(duì)於認(rèn)証範(fàn)圍之內(nèi)之產(chǎn)品具有設(shè)計(jì)/開發(fā)責(zé)任(designresponsible)，並且執(zhí)行(perform)該設(shè)計(jì)/開發(fā)(design&development)，或?qū)⒃撛O(shè)計(jì)/開發(fā)外包(委外)出去(outsource)執(zhí)行，那麼條文7.3(設(shè)計(jì)和開發(fā))必須納入品質(zhì)管理系統(tǒng)(QMS)之內(nèi)。換言之，條文7.3(設(shè)計(jì)與開發(fā))不可以排外。33DesignandDevelopment33DesignanddevelopmentISO9000:2000definition(Clause3.4.4)SetofprocessesthattransformsrequirementsintospecifiedcharacteristicsDistinguishingfeature(Physical,sensory,behavioural,Temporal,ergonomic,functional)Needorexpectationthatisstated,generallyimpliedorobligatory.34DesignanddevelopmentDistinguNOTE1theterms“design”and“development”aresometimesusedsynonymouslyandsometimesusedtodefinedifferentstagesoftheoveralldesignanddevelopmentprocess.e.g.software,治金業(yè)等習(xí)慣用development這個(gè)字，而不用design這個(gè)字。Customer/regulatory/productrequirements:designinput(客戶/法規(guī)/產(chǎn)品要求:設(shè)計(jì)輸入)ductcharacteristics/specifications:designoutput(產(chǎn)品特性/規(guī)格:設(shè)計(jì)輸出)-假如組織沒(méi)有被(客戶)提供產(chǎn)品特性(productcharacteristics)或產(chǎn)品規(guī)格(productspecifications)用以規(guī)劃其產(chǎn)品實(shí)現(xiàn)過(guò)程(productrealizationprocesses)，並且組織必須根據(jù)客戶或法規(guī)要求(customerand/orregulatorybodyrequirements)來(lái)定義(define)這些產(chǎn)品特性(或productspecifications)，此意為「產(chǎn)品設(shè)計(jì)與開發(fā)」(productdesignanddevelopment)。35NOTE1theterms“design”and-簡(jiǎn)言之，只要看「產(chǎn)品規(guī)格(ProductSpec.)制定者」是誰(shuí)即可很清楚釐清設(shè)計(jì)責(zé)任及「設(shè)計(jì)是否可以排外」之問(wèn)題。-ProductSpec.(產(chǎn)品規(guī)格)vs.ProcessSpec.(製程規(guī)格)e.g.電鍍廠/車體塗裝烤漆廠之認(rèn)証範(fàn)圍“The(designand)provisionofelectro-plating(或painting)”ISO/TS16949:2002TheonlypermittedexclusionsforthisTechnicalSpecificationrelateto7.3wheretheorganizationisnotresponsibleforproductdesignanddevelopment.Permittedexclusionsdonotincludemanufacturingprocessdesign.(製程設(shè)計(jì)不可以被排外)36-簡(jiǎn)言之，只要看「產(chǎn)品規(guī)格(ProductSpec.)附註:i)傳統(tǒng)之「設(shè)計(jì)與開發(fā)」(designanddevelopment)是針對(duì)有形之「產(chǎn)品」(product)，但亦適用於服務(wù)service(無(wú)形之產(chǎn)品)。

e.g.我看過(guò)國(guó)泰人壽之大幅廣告寫著ISO9002認(rèn)証，這樣對(duì)嗎？答:Yes,假如認(rèn)証範(fàn)圍只是國(guó)泰一個(gè)營(yíng)業(yè)所,負(fù)責(zé)拉保險(xiǎn),收費(fèi),客服…等

No,假如認(rèn)証範(fàn)圍是整個(gè)國(guó)泰集團(tuán)之作業(yè)…meaning有涵蓋「新保單」(其Serviceproduct)之產(chǎn)品設(shè)計(jì)與開發(fā)「ISO9001:19944.4設(shè)計(jì)管制」37附註:37ii)組織可以選擇將「設(shè)計(jì)與開發(fā)流程」(designanddevelopmentprocess)外包出去(outsource)，這種情況就需符合ISO9001:2000之clause4.1之“whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.ControlofsuchoutsourcedprocessesshallbeidentifiedwithintheQMS.3838iii)一個(gè)組織不一定對(duì)QMS所涵蓋範(fàn)圍之內(nèi)之所有產(chǎn)品都有設(shè)計(jì)/開發(fā)責(zé)任。iv)雖然「原始設(shè)計(jì)」不屬於某一組織，但該組織可能有「責(zé)任」及「權(quán)力」來(lái)變更產(chǎn)品規(guī)格或特性。此情況表示條文clause7.3(DesignandDevelopment)之某些「子條文」(subclauses)可能不適用，但不能將整個(gè)clause7.3完全排外。e.g. OEM:OriginalEquipmentManufacturer(原始設(shè)備製造商)

ODM:OriginalDesignManufacturer(原始設(shè)計(jì)製造商) EMS:ElectronicsManufacturingService(電子製造服務(wù)/電子代工業(yè)):臺(tái)灣已是全球之佼佼者。

39iii)一個(gè)組織不一定對(duì)QMS所涵蓋範(fàn)圍之內(nèi)之所有產(chǎn)品都v)QS-90004.4—Asupplierisdefinedasdesign-responsibleifithastheauthoritytoesbablishanew,orchangeanexistingproductspecificationforanyproductshippedtoacustomer.Customerapprovalofadesignresponsiblesupplier’sproductdoesnotwaivethesupplier’sdesignresponsiblestatus.:對(duì)於交運(yùn)給客戶之產(chǎn)品而言，如果該供應(yīng)商具有權(quán)力(authority)來(lái)建立該(新)產(chǎn)品之規(guī)格，或變更該產(chǎn)品之現(xiàn)行規(guī)格，均稱該供應(yīng)商具有設(shè)計(jì)責(zé)任(designresponsible)。即使客戶核準(zhǔn)(認(rèn)可)了具有設(shè)計(jì)責(zé)任之供應(yīng)商之產(chǎn)品(adesignresponsiblesupplier’sproduct)也不能免除該供應(yīng)商之設(shè)計(jì)責(zé)任。40v)QS-90004.4—40

FAQ:本公司並沒(méi)有設(shè)計(jì)開發(fā)部門(R&D),而且多年來(lái)一直都是生產(chǎn)非常成熟之UL線種SPT-1和SPT-2(根據(jù)UL62電線標(biāo)準(zhǔn)),此情況是否可將ISO9001:2000之7.3(設(shè)計(jì)和開發(fā))排外?Ifnot,在未來(lái)幾年,我們也可能無(wú)任何新設(shè)計(jì)案!?Ans:1.問(wèn)題不在有無(wú)R&D部門之設(shè)立,想一想product“characteristics”(distinguishingfeatures)/productspecs(designoutput)是誰(shuí)訂的?UL62電線標(biāo)準(zhǔn)只告訴你一些safetyrequirements(designinput),它並沒(méi)有告訴你其他non-safetyrequirements(e.g.顏色、外觀、花紋…)!如果組織必需根據(jù)客戶/UL安規(guī)要求(customer/ULsafetyrequirements:designinput)來(lái)定義(define)這些線種之產(chǎn)品特性/規(guī)格(productcharacteristics/specs:designoutpout)，或稱「開規(guī)格」，則該組織是有從事7.3「(產(chǎn)品)設(shè)計(jì)與開發(fā)」!41FAQ:本公司並沒(méi)有設(shè)計(jì)開發(fā)部門(R&D),而且多年2.想一想,7.3.3之Designanddevelopmentoutputs有那些規(guī)定:Theoutputsofdesignanddevelopmentshallbeprovidedinaformthatenablesverificationagainstthedesignanddevelopmentinputandshallbeapprovedpriortorelease.Designanddevelopmentoutputsshalla)meettheinputrequirementsfordesignanddevelopments,b)provideappropriateinformationforpurchasing,productionandforserviceprovision,c)containorreferenceproductacceptancecriteria,andd)specifythecharacteristicsoftheproductthatareessentialforitssafeandproperuse.上述之designoutputs是誰(shuí)訂的?如果是組織本身，那麼我們可以說(shuō)「組織俱有設(shè)計(jì)責(zé)任/能力」，不能將7.3排外!422.想一想,7.3.3之Designanddeve一般產(chǎn)品設(shè)計(jì)工程師所產(chǎn)出的Productspecification產(chǎn)品規(guī)格(designoutput)是為了下列用途:採(cǎi)購(gòu)、生產(chǎn)/製造、檢驗(yàn)、包裝、安裝、及使用…。註:(常見錯(cuò)誤)誤將工業(yè)標(biāo)準(zhǔn)/規(guī)格，安規(guī)/法規(guī)規(guī)定，客戶招標(biāo)規(guī)定當(dāng)成Productspecifications(designoutput)。事實(shí)上，這些通常是designinput亦即customer/product/regulatoryrequirements!43一般產(chǎn)品設(shè)計(jì)工程師所產(chǎn)出的Productspecific3.重點(diǎn):簡(jiǎn)單的設(shè)計(jì)(或設(shè)變)簡(jiǎn)單的7.3管制簡(jiǎn)單的「設(shè)計(jì)記錄/資料」(DesignRecords),i.e.DesignInputs(7.3.2),DesignReview(7.3.4),DesignVerification(7.3.5),DesignValidation(7.3.6)和DesignChanges(7.3.7)都規(guī)定要保留記錄。經(jīng)驗(yàn)告訴我們,一些傳統(tǒng)中小企業(yè)事實(shí)上有「開規(guī)格」生產(chǎn),但較不習(xí)於保留「設(shè)計(jì)記錄」。

443.重點(diǎn):簡(jiǎn)單的設(shè)計(jì)(或設(shè)變)簡(jiǎn)單的7.34.稽核7.3之a(chǎn)uditor必須具備行業(yè)背景,瞭解產(chǎn)品(特性),才能正確判斷是否有設(shè)計(jì)責(zé)任/排外。據(jù)聞過(guò)去有些認(rèn)証公司(Registrars)“鼓勵(lì)”有「設(shè)計(jì)責(zé)任」或「有從事產(chǎn)品設(shè)計(jì)與開發(fā)」之公司去申請(qǐng)ISO9002？！Applicabledesigninterfacestobeassessedatplantlevel→OEMvs.RemoteDesignCenter之情況Remarks:“Assessinginterfaces”startswithdeterminingresponsibilitiesandthecommunicationchannelsbetweenthelocations.Assesstheinputs/outputsusingtheprocessapproach.454.稽核7.3之a(chǎn)uditor必須具備行業(yè)背景,瞭解產(chǎn) Activities(Steps)vs.Process(流程)vs.ProcessApproach(流程導(dǎo)向/方式)觀念:?3puts:Input-Throughput「生產(chǎn)/Activities」-Output

?SetofinterrelatedorinteractingACTIVITIES(steps)whichtransformsinputsintooutputs.(將輸入轉(zhuǎn)換成輸出之交互作用之活動(dòng))

?APROCESSisanysetofassociatedACTIVITIES(steps)havinginputsandgeneratingoutputs.(具有輸入,並且能產(chǎn)生輸出之任何交互作用之活動(dòng)稱為一個(gè)“流程”「process」)46 Activities(Steps)vs.Proce?Foranorganizationtofunctioneffectivelyandefficiently,ithastoidentifyandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,isconsideredasaprocess.Oftentheoutputfromoneprocessdirectlyformstheinputtothenext.(一個(gè)組織之有效運(yùn)作在於它需鑑別及管理眾多之「環(huán)環(huán)相扣之活動(dòng)」。假如有一項(xiàng)活動(dòng),它使用了資源,並且「被管理」,以至於能將輸入轉(zhuǎn)換成輸出,我們稱該項(xiàng)活動(dòng)為一過(guò)「流程」)。通常一個(gè)流程之輸出直接構(gòu)成了下一個(gè)流程之輸入。?Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsandmanagingoftheseprocessescanbereferredtoasthe“processapproach”.那麼,何謂「流程導(dǎo)向/方式」呢?一個(gè)組織內(nèi)之所有流程之有系統(tǒng)之結(jié)合與運(yùn)作,加上對(duì)這些流程之鑑別,交互作用及管理,稱之為「流程導(dǎo)向/方式」。

47?Foranorganizationtofunc ?Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellastheircombinationandinteraction.

「流程導(dǎo)向」其中一個(gè)好處是,它能針對(duì)「流程系統(tǒng)內(nèi)的各個(gè)流程之間之連結(jié),組合以及交互作用提供持續(xù)性之控管」。48 ?Anadvantageoftheprocess

WhenusedwithinaQMS,suchanapproachemphasizestheimportanceofUnderstandingandfulfillingtherequirements,Theneedtoconsiderprocessesintermsofaddedvalue,Obtainingresultsofprocessperformanceandeffectiveness,andContinualimprovementofprocessesbasedonobjectivemeasurement.如將「流程導(dǎo)向」應(yīng)用於品質(zhì)管理系統(tǒng),它能強(qiáng)化下列各項(xiàng)之重要性:

瞭解及滿足(符合)規(guī)定,需要以是否能提高附加價(jià)值來(lái)思考流程,取得流程績(jī)效/表現(xiàn)及效果之結(jié)果,和

依據(jù)客觀量測(cè)而進(jìn)行之流程之持續(xù)改善。49 WhenusedwithinaQMS,suchPROCESS(“Setofinterrelatedorinteractingactivities”)INPUTOUTPUTMONITORINGANDMEASUREMENTOPPORTUNITIES

(Before,duringandaftertheprocess)PRODUCT(“Resultofaprocess”)PROCEDURE

(“Specifiedwaytocarryoutanactivityoraprocess”–maybedocumentedornot)EFFECTIVENESSOFPROCESS=ABILITYTOACHIEVEDESIREDRESULTS(FocusofISO9001:2000)EFFICIENCYOFPROCESS=Resultsacievedvsresourcesused(FocusofISO9004:2000)(IncludesResources)FocusofTS-2:Effectiveness+Efficiency50PROCESSINPUTOUTPUTMONITORINGAPDCA/PDSA(Plan-Do-Check-Act或Plan-Do-Study-Act:計(jì)劃-執(zhí)行-檢討-改善):Processapproach是遵循PDCA管理/改善循環(huán): *Definethework(Plan計(jì)劃) *Executethework(Do執(zhí)行) *Measuretheresults(Check檢討) *Identifyimprovements(Act改善):含CI,CA&PAISO9001:2000更強(qiáng)調(diào)“Plan”和“Act”,此兩項(xiàng)是多數(shù)公司較弱之地方。(e.g.SPC/ControlCharts,FMEA等手法之使用:“Nicechart,butnoaction”※或有“s(statistics)”，沒(méi)有“PC(ProcessControl)”Useless!)51PDCA/PDSA(Plan-Do-Check-Act或

Act●HowtoimproveNexttime?

Plan●Whattodo? ●(“Objective”)●Howtodoit? ●(“Procedure/method”)

Check●Didthingshappenaccordingtoplan?

Do●Dowhatwasplanned“Theobjectivew/omethodisuseless”Better(Q)Cheaper(C)Faster(D)“Monitorandmeasureprocessesandproductagainstpolicies,objectiveandrequirementsfortheproductandreporttheresults.Check:52ActPlanCheckDo“PDCAvs.ProcessApproach/InteractionACPDEXTERNALCUSTOMEREXTERNALCUSTOMERPADCPROCESSAPROCESSBPADCPADCPROCESSCPADCPROCESSEPADCPROCESSDPADCPROCESSFInternalCustomerInternalCustomerFeedbackOutputDOutputEInputAInputBOutputAOutputBInputCInputFOutputFOutputCInputDInputENewprocess:從PDCA的P開始轉(zhuǎn)Existingprocess:從PDCA的C開始轉(zhuǎn)53PDCAvs.ProcessApproach/Inte

PROCESSCONTROLSYSTEMMODELWITHFEEDBACKTHEWAYWEWORK/BLENDINGOFRESOURCESSTATISTICALMETHODSVOICEOFTHEPROCESSMENMACHINESMATERIALSMETHODSENVIRONMENTVOICEOFCUSTOMERSCUSTOMERSIDENTIFYINGCHANGINGNEEDSANDEXPECTATIONSINPUTS

PROCESS/SYSTEM

OUTPUTSPRODUCTSORSERVICES54PROCESSCONTROLSYSTEMMODEL55558.Measurement,AnalysisandImprovementProcessesExamples:Processestodemonstrate:ConformityofproductConformityofmanagementsystemContinualimprovement5.TOPManagementProcessesExamples:ProcesstodefinequalitypolicyandobjectivesCommunicationprocessManagementreview6.ResourceManagementProcessesExamples:DeterminationandprovisionofresourcesHumanresourcesInfrastructuredefinitionWorkenvironmentdefinition7.ProductRealizationProcessesExamples:?PlanningCustomerrelatedprocessesDesign&developmentprocessPurchasingprocessProduction&serviceprovisionControlofmonitoringandmeasuringdevices(Fig1)4.1QualityManagementSystemProcesses568.Measurement,Analysis5.TOCorrectIdentifyCoreProcesses(COP’s)Needs&ExpectationsImprove?

ProcessDesignProductDesignANODYESCustomersOK?CCheckResultsP57CorrectIdentifyCoreProcesses ?ISO9001:20008.2.3Monitoringandmeasurementofprocesses(流程之監(jiān)督與量測(cè)) Theorganizationshallapplysuitablemethodsformonitoringand,whereapplicable,measurementoftheQMSprocesses.Thesemethodsshalldemonstratetheabilityoftheprocessestoachieveplannedresults.Whenplannedresultsarenotachieved,correctionandcorrectiveactionshallbetaken,asappropriate,toensureconformityoftheproduct.

(組織必須使用適當(dāng)之方法來(lái)監(jiān)督和,必要時(shí),量測(cè)QMS之流程。這些方法必須能展示這些流程能達(dá)成既定/預(yù)期之結(jié)果。當(dāng)達(dá)不到既定/預(yù)期之結(jié)果時(shí),組織必須採(cǎi)取適當(dāng)之改正及矯正措施,以確保產(chǎn)品能符合規(guī)定)。

58 ?ISO9001:20008.2.3Monito ?ISO9004:20008.2.2Measurementandmonitoringofprocesses(流程之量測(cè)與監(jiān)督) Theorganizationshouldidentifymeasurementmethodsandshouldperformmeasurementstoevaluateprocessperformance.Theorganizationshouldincorporatethesemeasurementsintoprocessesandusethemeasurementsinprocessmanagement.(組織應(yīng)該鑑別量測(cè)方法,而且應(yīng)該執(zhí)行量測(cè),用以評(píng)估流程之績(jī)效。組織應(yīng)該將這些量測(cè)溶入流程之中,並且使用這些量測(cè)來(lái)做流程管理)。59 ?ISO9004:20008.2.2Measur意即:「Ifyoucan’tmeasureit,youcan’tmanageit!(如果你不能衡量它，就無(wú)法管理它!)」。如果某一個(gè)量度缺乏支持的資料(i.e.missingmeasurements)，問(wèn)題可能是某一個(gè)主要策略目標(biāo)的管理流程未臻完善(robust)或根本不存在。既然某一缺乏量測(cè)資料(missingmeasurements)之“關(guān)鍵績(jī)效量度指標(biāo)”(KeyMeasurable/KPI)是組織之seniormanagement共同決議產(chǎn)生的，則組織必須建立一個(gè)新流程來(lái)產(chǎn)生這些KPI’s所需要之data，千萬(wàn)不可陷入錯(cuò)誤的迷思:「Wecan’tmeasurewhatwewant,sowehavedecidedtowantwhatwecanmeasure!」另,GEJackWelch名言:「Whatyoumeasureiswhatyouget—whatyourewardiswhatyouget!」60意即:「Ifyoucan’tmeasureit,yMeasurementsshouldbeusedformanagingdailyoperations,forevaluationoftheprocessesthatmaybesuitableforsmall-steporongoingcontinualimprovements,aswellasforbreakthroughprojects,accordingtothevisionandstrategicobjectivesoftheorganization.(根據(jù)所訂之願(yuàn)景和策略目標(biāo),組織應(yīng)該使用量測(cè)來(lái)管理日常作業(yè),來(lái)評(píng)估流程,不管該流程是適合逐步漸進(jìn)式的持續(xù)改善,或突破式的流程/企業(yè)再造工程)。61MeasurementsshouldbeusedfoMeasurementsofprocessperformanceshouldcovertheneedsandexpectationsofinterestedpartiesinabalancedmanner(e.g.BSC).Examplesinclude以追求各個(gè)不同構(gòu)面之間之平衡，流程績(jī)效之量測(cè)應(yīng)該涵蓋相關(guān)利益團(tuán)體之需求和期望?？赡苤繙y(cè)指標(biāo)有:-capability,(製程能力,e.g.Cpk)-reactiontime,(反應(yīng)/回覆時(shí)間)-cycletimeorthroughpute.g.製造週期效能(manufacturingcycleeffectiveness,MCE)=加工時(shí)間(ProcessingTime)

產(chǎn)出時(shí)間(ThroughputTime)-measurableaspectsofdependabi